Remifentanil Dosing Regimes for Anesthesia in Bariatric Surgery: Characteristics of Early Recovery

Morbid Obesity Clinical Trial

Official title:

Remifentanilio Titravimo būdų Palyginimas, Remiantis pacientų Budimo Kokybe Ligotai Nutukusiems Pacientams po laparoskopinių skrandžio tūrio mažinimo operacijų

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690088
• Other study ID #: BEC - MF - 93
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: December 2020
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Early recovery characteristics are important for patients' safety and operating room turnover. Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Description:

Introduction: The population of overweighted patients is increasing dramatically, therefore physicians face them in their daily practice (1-2). There are many guidelines showing the dose counting methods of intravenous anesthetics, but none of them are perfectly good for morbidity obese patients (3). Early recovery characteristics are important for patients' safety and operating room turnover (4).

Aim: Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Methods: 31 patients were evaluated who underwent bariatric surgery in Hospital of Lithuanian University of Health Sciences. All of them had received sevoflurane/remifentanil anaesthesia. Remifentanil infusion was randomly assigned to a manual (control group) or to a TCI (case group) method. We had evaluated patients' hemodynamics (arterial blood pressure, heart rate, saturation), spontaneous breathing and airway reflexes recovery time, time of extubation, eye opening, recovery of orientation and start of the following oral command. Also we had registered concentrations of remifentanil in the blood (according to automatic infusion pump) while using TCI method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 10, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 57 Years

Eligibility

Inclusion Criteria:

• Morbid patients to whom, according guidelines (BMI > 45 or BMI > 35 and chronic disease) bariatric surgery is indicated.

• Patient's approval.

Exclusion Criteria:

• Patients, younger than 18 years old.

• Patients who are higher than III ASA class.

• Patients who have higher sensibility to medications that are used during anesthesia.

• Patients with phycological disorders.

• Patients who can not fully communicate because of language barriers.

• Patients with surgical complications.

• Patient's disapproval.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

References & Publications (5)

Adams JP, Murphy PG. Obesity in anaesthesia and intensive care. Br J Anaesth. 2000 Jul;85(1):91-108. Review. — View Citation

Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000 Sep;39(3):215-31. Review. — View Citation

Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. Review. Erratum in: Obes Res 1998 Nov;6(6):464. — View Citation

Egan TD, Kern SE, Muir KT, White J. Remifentanil by bolus injection: a safety, pharmacokinetic, pharmacodynamic, and age effect investigation in human volunteers. Br J Anaesth. 2004 Mar;92(3):335-43. — View Citation

Michelsen LG, Hug CC Jr. The pharmacokinetics of remifentanil. J Clin Anesth. 1996 Dec;8(8):679-82. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eye opening	The time of patient's respond after the end of remifentanyl infusion	up to 20 minutes
Primary	spontaneous breathing	The time of patient's respond after the end of remifentanyl infusion	up to 20 minutes
Primary	airway reflexes	The time of patient's respond after the end of remifentanyl infusion	up to 20 minutes
Primary	orientation	The time of patient's respond after the end of remifentanyl infusion	up to 20 minutes
Primary	oral command	The time of patient's respond after the end of remifentanyl infusion	2,4,6,8,10,12,14,16,18,20 minutes
Secondary	Heart rate	Measure was started after the end of remifentanyl infusion	up to 20 minutes
Secondary	Arterial blood pressure	Measure was started after the end of remifentanyl infusion	up to 20 minutes
Secondary	Saturation	Measure was started to record after the end of remifentanyl infusion	up to 20 minutes
Secondary	Remifentanyl dose	The amount of medication used during surgery	up to 20 minutes after surgery

External Links

•   Body - Mass index. Evaluation of BMI over time.
•   Cortrnez L I, Anderson B J. Current Opinion in Anaesthesiology 2018; 31(4):415-422.
•   Egan T D. Remyfentanil Pharmacocinetics and Pharmacodynamics. Clin. Pharmacokinet 1995; 29:80.
•   Valstybine vaistu kontroles tarnyba. Remifentanil Kabi.